Most parents think nothing of giving their child a dose of Tylenol or Motrin for a fever. Plaintiffs in Reckis v. Johnson & Johnson didn’t either, although the child’s father was careful to say he’d read the warning on the back of the bottle. Nothing on that label indicated that his child might run the risk of developing a severe, life-threatening skin reaction to the medication.
Had he seen that, he later told jurors, he would never have given his daughter the medication for a persistent fever. But there was no such warning on the label, and the child did develop just such an infection. As a result, she almost died. Her recovery has been slow and painful. In fact, she will never fully recover. She will likely be dependent on someone for basic daily tasks for the rest of her life.
The drug company knew such a reaction was a risk, but it argued any labeling lawsuits were preempted by federal law. Jurors who heard the case within a Massachusetts trial court disagreed, as did the panel of justices for the Massachusetts Supreme Judicial Court, which recently affirmed the $63 million judgment favoring the child and her parents.
According to court records, this product liability lawsuit began in November 2003, when a seven-year-old girl was suffering from a fever and stuffy nose. Her father purchased a bottle of Children’s Motrin over-the-counter. The active ingredient is ibuprofen. The father administered a dose at 2 p.m. and again at 10 p.m. The next morning, the child was suffering from a rash and sore throat, in addition to the fever and congestion. He gave her a third dose of the medication. There was no warning on the medication indicating not to proceed with the medication if a rash, redness, or blisters appeared.
In fact, what the child was suffering from – but would not be known until later – was a condition known as Stevens-Johnson Syndrome, also referred to as TEN (toxic epidermal necrolysis). But because there was no warning on the label, the girl’s pediatrician administered an additional dose, as did staffers at a local hospital where she was soon admitted when her condition worsened.
Her eyes were crusty. Her lips were cracked. Her rash worsened. She developed blisters all over her body. Her eyes, mouth, and lips were bleeding.
Doctors at the hospital feared she wouldn’t live through the night. She was placed in a medically induced coma for a month and remained hospitalized for six months. The entire top layer of her skin died. She suffered a stroke and aneurysm. She suffered cranial hemorrhages and seizures. She underwent brain surgery. Her lung capacity fell dangerously low, as did her weight. Her eyes remained inflamed. She suffered extreme withdrawal symptoms when doctors tried to wean her from the narcotics they’d initially given her to ease her pain. She weighed just 35 pounds when released from the hospital.
Her health struggles continued and go on to this day. Although she returned to school and now hopes to someday attend college, her cognitive function has also been significantly diminished, and she requires constant care, including a feeding tube. She will never be able to participate in athletics or have a child or drive a car. She is also legally blind.
Jurors heard all of this, and the fact that the known danger was never printed on the warning label of the medicine bottle. Granted, the disease is rare. When it does strike, it’s fatal in about one-third of all cases.
The warning label did say to discontinue if an allergic reaction occurs, but there was no mention of SJS, TEN, or the risk of rash, blisters, skin reddening, or the possibility of a life-threatening illness.
A citizen petition filed in 2006 with the U.S. Food & Drug Administration asked for a formal review of the risk of these diseases associated with ibuprofen. The FDA requested manufacturers of this medication include a warning regarding TEN and SJS and specifically rash, blisters, and skin reddening. The warning is also to include the notation that if symptoms are recognized promptly and the drug is discontinued, the drug’s effects are minimized and prognosis is improved.
This complaint was filed in 2007, and it alleged negligence, breach of warranty, and failure to warn of potentially lethal side effects, loss of consortium, and negligent infliction of emotional distress.
Jurors sided with the plaintiffs, awarding $50 million to the girl and $6.5 million each to her parents.
The defense appealed, arguing that the failure to warn claim was preempted by federal law, that the plaintiff’s expert witness was not qualified to testify as to medical causation, and that damages were grossly excessive. The Maine Supreme Judicial Court affirmed on each count, meaning the $63 million verdict will stand.
The Ferraro Law Firm handles claims resulting from defective medical products or dangerous pharmaceuticals. Call 1-800-275-3332 for a free and confidential consultation. Offices in Miami and Washington, D.C.
Reckis v. Johnson & Johnson, April 17, 2015, Massachusetts Supreme Judicial Court
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